Continuous Improvement Lead - Vaccine Manufacturing (DS&DP

Continuous Improvement Lead (CI) - VDSP, Lalru & VDPP, Baddi

Reports To : Strategic Project Manager (SPM)

Department : COO – Vaccine

Job Location :

VDSP, Lalru & VDPP, Baddi

Role Summary :

To lead and institutionalize continuous improvement (CI) initiatives across the WHO prequalified vaccine manufacturing facility by driving cost reduction, waste elimination, energy optimization,yield improvement and process excellence. The role promotes a culture of innovation, quality initiatives and operational efficiency aligned with cGMP, WHO, and other global regulatory standards.

Key Responsibilities :

1. Continuous Improvement & Operational Excellence

Identify and execute improvement projects focused on yield improvement, cycle time reduction, cost savings, and resource optimization.

Promote Lean, Six Sigma, and Kaizen practices across all manufacturing and support functions.

Drive initiatives such as 5S, Visual Management, TPM, to enhance efficiency and reduce variability.

Implement SPC(Statistical Process Control0 and SQC ( Statistical Quality Control)

2. Regulatory Compliance & GMP Alignment

Ensure CI initiatives are aligned with WHO, USFDA, EU-GMP, and cGMP requirements.

Support validation and qualification teams in improving process robustness and data integrity.

Collaborate with QA, QC, and Regulatory Affairs to maintain compliance while improving systems and procedures.

Work closely with manufacturing, QA, QC, RA, Engineering & SCM heads to identify bottle necks and area for improvement.

Partner with functional leaders to standardize processes and reduce variation across plants or departments

Facility CI project governance, tracking, reporting & escalation to COO

3. CI Project Leadership & Execution

Lead cross-functional CI projects across Drug Substance Plant , Drug Product, Formulation, Filling, and Packaging areas.

Develop project charters, timelines, and ROI analysis; track benefits and report to leadership.

Facilitate Kaizen events and root cause investigations (using 5 Whys, Fishbone, FMEA, etc.).

4. Capability Building & Cultural Transformation

Train employees at all levels in Lean principles, Six Sigma tools, and structured problem-solving.

Build CI mind-set across production, quality, engineering, and warehouse teams.

Conduct Gemba walks, performance huddles, and innovation forums to engage teams.

5. Performance Monitoring & Reporting

Establish CI metrics and dashboards (OEE, Waste %, Yield, Downtime, etc.) and monitor regularly.

Track CAPA effectiveness, deviation trends, and quality improvements as part of the CI program.

Qualifications & Experience :

Bachelors or Master’s degree in Engineering, Pharmacy, Biotechnology, or Life Sciences.

Certified Lean Six Sigma Green Belt or Black Belt (preferred).

Minimum 6–10 years of demonstrated relevant experience in vaccine / biotech / pharma manufacturing, preferably in a WHO-GMP or global regulatory-compliant facility.

Key Skills & Competencies :

Strong understanding of GMP, WHO, and global vaccine manufacturing regulations

Proven expertise in Lean, Six Sigma, and Kaizen tools

Analytical, data-driven decision-making

Strong facilitation, coaching, and change management skills

Cross-functional leadership and collaboration abilities

Proficiency in using CI tools / software (e.g., Minitab, Power BI, etc.)